Phase I (safety) study of autologous tolerogenic dendritic cells in type 1 diabetic patients.

ABSTRACT:

Objective

The safety of dendritic cells to selectively suppress autoimmunity, especially in type 1 diabetes, has never been ascertained. We investigated the safety of autologous dendritic cells, stabilized into an immunosuppressive state, in established adult type 1 diabetic patients.

Research design and methods

A randomized, double-blind, phase I study was conducted. A total of 10, otherwise generally healthy, insulin-requiring type 1 diabetic patients between 18 and 60 years of age, without any other known or suspected health conditions, received autologous dendritic cells, unmanipulated or engineered ex vivo toward an immunosuppressive state. Ten million cells were administered intradermally in the abdomen once every 2 weeks for a total of four administrations. The primar

SUBMITTER: Giannoukakis N 

PROVIDER: S-EPMC3161299 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature